Prospective Trial for Examining Hematuria Using Computed Tomography

  • STATUS
    Recruiting
  • End date
    Sep 1, 2021
  • participants needed
    250
  • sponsor
    Oslo University Hospital
Updated on 24 March 2021

Summary

The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urinary tract cancer in patients with hematuria compared to the traditional four-phase CT (control).

Description

Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.

Study type: Prospective clinical trial

Study design: One sample, non-inferiority study with a 7.5% non-inferiority limit.

Investigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm)

Objective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urinary tract cancer in patients with hematuria compared to the traditional four-phase CT (control).

Primary endpoints: The difference in false negative rates in the experimental- and control arm. McNemara is used for statistical analyses.

there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm

Sample size:

250 patients

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Transitional cell carcinoma, Renal Cell Carcinoma, Cystic kidney disease, Nephrolithiasis, KIDNEY STONE, Kidney Cancer, Kidney Stones, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Urothelial Carcinoma, clear cell renal cell carcinoma, renal stones
Treatment CT
Clinical Study IdentifierNCT04077359
SponsorOslo University Hospital
Last Modified on24 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Stones or Cystic kidney disease or Renal Cell Carcinoma or Transitional cell carcinoma or Malignant Adenoma or Urothelial Carcinoma or clear ce...?
Do you have any of these conditions: renal stones or Renal Cell Carcinoma or Cystic kidney disease or Kidney Stones or Transitional cell carcinoma or Urothelial Carcinoma or clear cell re...?
Do you have any of these conditions: Nephrolithiasis or renal stones or Malignant Adenoma or Adenocarcinoma or Kidney Cancer or Renal Cell Cancer or Renal Cancer or Malignant neoplasm of ...?
One or more occasion with macroscopic hematuria without signs of urinary tract infection
>18 years old

Exclusion Criteria

Previous history of cancer in the urinary tract
Known staghorn calculi
Previous iodine contrast medium allergy reaction
For any reason, do not wish to participate in the study
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note